| CTRI Number |
CTRI/2018/04/013478 [Registered on: 25/04/2018] Trial Registered Prospectively |
| Last Modified On: |
18/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of local anaesthetic for reducing pain during vaccination |
|
Scientific Title of Study
|
STUDY OF REDUCING PAIN BY TOPICAL ANAESTHETIC IN INFANTS DURING DPT COMBO VACCINATION: RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mehul M Gosai |
| Designation |
Associate Professor |
| Affiliation |
Government. Medical College, Bhavnagar |
| Address |
Room no 2, first floor, Baby Medical Ward-1, department of pediatrics, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426804255 |
| Fax |
|
| Email |
drmehulgosai78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehul M Gosai |
| Designation |
Associate Professor |
| Affiliation |
Government. Medical College, Bhavnagar |
| Address |
Room no 2, baby Medical Ward-1, department of pediatrics, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426804255 |
| Fax |
|
| Email |
drmehulgosai78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehul M Gosai |
| Designation |
Associate Professor |
| Affiliation |
Government. Medical College, Bhavnagar |
| Address |
Room no 2, Baby Medical Ward-department of pediatrics, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426804255 |
| Fax |
|
| Email |
drmehulgosai78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics, Government medical College, bhavnagar
|
|
|
Primary Sponsor
|
| Name |
Pediatrics Department |
| Address |
Pediatrics Department, Government. Medical College, Bhavnagar
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mehul M Gosai |
Sir Taktasinhji Hospita |
Department of pediatrics, sir T hospital, Jail Road, Bhavnaga
Bhavnagar
GUJARAT |
9426804255
drmehulgosai78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Infants
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lidocaine-prilocaine 5% |
topical anesthetic patch |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy infant aged 1 month to 1 year
|
|
| ExclusionCriteria |
| Details |
1.Age less than 1 month
2.Age more than 12 month
3.Neonates who were delivered before 37 week
4.Congenital anomalies
5.Child with central nervous system related diseases
History of adverse effect or allergy with previous vaccination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score will be assessed in both the groups and compared |
Within 10 minutes duration pain score will be assessed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of topical anaesthetic cream prior to vaccination will be assessed |
After topical application of cream in 10 minutes duration effectiveness will be assessed
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
50 subjects will be observed for pain score after giving dpt vaccine after topical anaesthetic application and compared with subjects receiving DPT without local anaesthetic application... Pain score between the two groups will be compared using unpaired t test to determine if local anaesthetic application reduce pain
|
|